Long-term safety study of Temferon (modified stem cells with interferon-α2) in patients previously treated for glioblastoma multiforme

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What is this study about?

This study focuses on patients with Glioblastoma Multiforme, an aggressive type of brain cancer. The study evaluates the long-term safety of a treatment called Temferon, which was previously given to patients. Temferon is a special type of therapy that uses the patient’s own blood stem cells that have been modified to carry a specific gene.

The treatment involves hematopoietic stem cells (blood-forming cells) that are collected from the patient’s own body. These cells are modified in a laboratory to include a gene that produces interferon alpha-2, a substance that can help fight cancer. The modified cells are then given back to the patient through an intravenous infusion (through a vein).

The main purpose of this follow-up study is to monitor the long-term safety of Temferon treatment. The study will specifically look at whether the modified cells could potentially cause any blood disorders or other health issues over time. Patients who have previously received Temferon treatment will be monitored for several years to ensure their safety and to track how well the treatment continues to work.

1 Initial participation

You have previously received Temferon treatment and completed the initial TEM-GBM_001 study.

You will be monitored for long-term effects of the treatment through regular check-ups.

2 Medical monitoring

Your blood will be regularly tested to check for any changes in white blood cells.

Regular clinical examinations and laboratory tests will be conducted to monitor your health.

Your brain condition will be evaluated using standard medical imaging to track any changes.

3 Safety assessments

Doctors will monitor for any signs of blood disorders or changes in your immune system.

Your neurological health will be regularly assessed for any new symptoms not related to your original condition.

Any infections or unexpected health changes will be documented and evaluated.

4 Treatment response evaluation

Your response to the previous Temferon treatment will be evaluated using standard medical criteria.

The medical team will assess if your condition is stable, improving, or changing.

Your overall health and survival will be monitored from the day you received Temferon.

5 Long-term follow-up

The monitoring period will continue until April 30, 2027.

Regular appointments will be scheduled to track your progress and health status.

All findings will be documented to understand the long-term effects of the treatment.

Who Can Join the Study?

Must be 18 years or older
Must have previously participated in the TEM-GBM_001 study and completed all follow-up visits
Must have previously received Temferon treatment (a type of medical therapy)
Must be able and willing to provide written informed consent (formal agreement to participate)
Must be willing to follow all study procedures and requirements
Can be either male or female
Must have been diagnosed with glioblastoma multiforme (a type of brain tumor)

Who Cannot Join the Study?

Age under 18 or over 65 years old
Pregnant or breastfeeding women
History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Active or chronic infections, including HIV, Hepatitis B, or Hepatitis C
Severe kidney problems (creatinine clearance less than 60 mL/min)
Severe liver problems (liver enzymes more than 3 times the normal upper limit)
Heart conditions including heart failure, recent heart attack, or irregular heartbeat
Uncontrolled high blood pressure (blood pressure higher than 150/90 mmHg)
History of autoimmune diseases (conditions where the immune system attacks healthy cells)
Mental health conditions that could affect ability to provide informed consent
Current participation in other clinical trials
Known allergies to any components of the study treatment
Life expectancy less than 3 months
Unable to undergo MRI scans (such as having metal implants or claustrophobia)
History of substance abuse in the past 2 years

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	14.06.2021

Trial locations

Investigated drugs:

Autologous Cd34+ Haematopoietic Stem And Progenitor Cells Transduced With A Lentiviral Vector Encoding The Interferon Alpha-2 Gene

Temferon is a specialized cell therapy that uses the patient’s own blood stem cells (CD34+ cells). These cells are modified in a laboratory using a special virus carrier (lentiviral vector) to make them produce interferon-α2, a protein that helps fight cancer. The modified cells are then given back to the patient to help treat glioblastoma multiforme, a type of brain cancer. This therapy aims to deliver targeted treatment directly to the tumor area.

Interferon-α2 is a natural protein that the body produces to fight diseases. In this treatment, it is produced by the modified cells to help combat the brain tumor. It works by boosting the immune system and potentially slowing down tumor growth.

Investigated diseases:

Glioblastoma multiforme

Glioblastoma multiforme (GBM) – A type of brain cancer that forms from glial cells, which normally support and protect nerve cells in the brain. It is characterized by the rapid growth of abnormal cells that form tumors in the brain tissue. The disease affects the cerebral hemispheres of the brain, though it can develop in other parts of the brain as well. GBM can cause various symptoms depending on its location, including headaches, seizures, changes in behavior, and problems with memory or speech. The tumor typically grows and spreads quickly within brain tissue, creating pressure within the skull.

Trial ID:

2024-516211-25-00

Protocol code:

TEM-LT

Trial Phase:

Human Pharmacology (Phase I) – Other

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Long-term safety study of Temferon (modified stem cells with interferon-α2) in patients previously treated for glioblastoma multiforme

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?